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Notice to Readers Food and Drug Administration Approval of an Acellular Pertussis Vaccine for the Initial Four Doses of the Diphtheria, Tetanus, and Pertussis Vaccination Series

MMWR 45(31);676-7

Publication date: 08/09/1996

Table of Contents





The Advisory Committee on Immunization Practices (ACIP) and the Committee on Infectious Diseases, American Academy of Pediatrics, recommend that children routinely receive a series of five doses of vaccine against diphtheria, tetanus, and pertussis before age 7 years (1,2). On July 31, 1996, the Food and Drug Administration licensed Connaught Laboratories, Inc. * (Swiftwater, Pennsylvania), to distribute a combined diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (Tripedia{Registered} ** ), for the initial four doses of the diphtheria, tetanus, and pertussis vaccination series. Vaccine doses should be administered at ages 2 months, 4 months, 6 months, and 15-20 months, with an interval of at least 6 months between the third and fourth doses. Available data are insufficient to evaluate the use of Tripedia{Registered} as a fifth dose among children aged 4-6 years who have received Tripedia{Registered} for the previous four doses. Additional information about the immunogenicity and safety of a fifth dose following four previous doses of the same acellular vaccine is being collected and should be available before infants started on this new schedule are aged 4-6 years and require a fifth dose.

Tripedia{Registered} is the first acellular pertussis vaccine to be licensed in the United States for the first three doses of the diphtheria, tetanus, and pertussis vaccination series. Tripedia{Registered} may be used to complete the primary series in infants who have received one or two doses of diphtheria and tetanus toxoids and whole-cell pertussis vaccine (DTP). For children who have received DTP for the first three doses of the series, two acellular pertussis vaccines (Tripedia{Registered} and ACEL-IMUNE{Registered} {Wyeth-Lederle Vaccines and Pediatrics (Pearl River, New York)}) already are licensed for the fourth and fifth doses of the series (3,4). The fifth dose of either DTaP or DTP is not necessary if the fourth dose was administered on or after the fourth birthday (1,2).

The following evidence supports use of Tripedia{Registered} for the first four doses of the diphtheria, tetanus, and pertussis vaccination series:

1. The rates of local reactions, fever, and other common systemic symptoms following receipt of Tripedia{Registered} inoculations are lower than those following whole-cell DTP vaccination for each of the first four doses in the series (3,5; Connaught Laboratories, Inc., unpublished data).

2. The protective efficacy of three doses of Tripedia{Registered} against pertussis disease (defined as cough lasting greater than or equal to 21 days with culture confirmation of infection with Bordetella pertussis) when administered at approximately 3, 5, and 7 months of age was 80% (95% confidence interval {CI}=59%-90%) in a case-control study in Germany (Connaught Laboratories, Inc., unpublished data). In a randomized, placebo-controlled clinical trial in Sweden, the acellular component of this vaccine manufactured by BIKEN, Inc., was administered as a two-dose series to children aged 5-14 months (6). Point estimates of protective efficacy were 69% (95% CI=47%-82%) for cases of culture-confirmed pertussis with any cough lasting greater than or equal to 1 day and 79% (95% CI=57%-90%) for cases of culture-confirmed disease of greater than 30 days' duration.

Because of the reduced frequency of adverse reactions and high efficacy, the ACIP recommends DTaP for routine use as the first four doses of the pertussis vaccination series. During the transition period from use of whole-cell DTP to DTaP, vaccines containing a whole-cell pertussis component continue to be an acceptable alternative for all doses in the pertussis vaccination series. A complete statement by the ACIP about recommendations for use of DTaP among infants is being developed.



  1. ACIP. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures -- recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-10).
  2. American Academy of Pediatrics. Report of the Committee on Infectious Diseases. Elk Grove Village, Illinois: American Academy of Pediatrics, Committee on Infectious Diseases, 1991.
  3. CDC. Pertussis vaccination: acellular pertussis vaccine for the fourth and fifth doses of the DTP series -- update to the supplementary ACIP statement. Recommendations of the Advisory Committee on Immunization Practices. MMWR 1992;41(no. RR-15).
  4. CDC. Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use -- supplementary ACIP statement. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1992;41(no. RR-1).
  5. Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13 acellular pertussis vaccines: adverse reactions. Pediatrics 1995;96(suppl):557-66.
  6. Ad Hoc Group for the Study of Pertussis Vaccines. Placebo-controlled trial of two acellular pertussis vaccines in Sweden -- protective efficacy and adverse events. Lancet 1988;1:955-60.
* Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services.

** Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed, prepared and distributed by Connaught Laboratories, Inc. The purified acellular pertussis component is produced by BIKEN/Tanabe Corporation (Osaka, Japan) and is combined with diphtheria and tetanus toxoids manufactured by Connaught Laboratories, Inc.


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